Nucleic acid synthesis screening at an inflection point: U.S. policy momentum and global implications.

Abstract

This article examines the positioning of nucleic acid synthesis screening (NASS) policy within the current U.S. political landscape, tracing its evolution from voluntary industry practices to executive and legislative action across administrations. We analyze the sources of NASS's political momentum, including the rare convergence of bipartisan national security imperatives, industry support for codified screening requirements, and biosecurity-related incidents. We assess key policy challenges, including navigating jurisdictional limitations and congressional gridlock, the risk of regulatory capture, and ensuring regulatory frameworks remain adaptive to evolving technologies. We situate U.S. efforts within an international context, examining parallel initiatives in the United Kingdom, the European Union, and New Zealand, noting how U.S. market-access requirements may promote de facto global screening adoption through economic incentives rather than multilateral diplomacy. We recommend specific policy instruments, such as expanding the U.S.-based third-party screening industry, leveraging federal procurement requirements, aligning with ISO standards, and building on NIST's maturing capability-based benchmarks, to establish enforceable domestic requirements while extending global reach.